CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
IQvitals Zone, automatically recalled by Midmark
Midmark is recalling IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood, distributed nationwide in the US. The recall was initiated on 21 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3217-2026
- FDA event ID
- 99641
- Recalling firm
- Midmark, Versailles, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2026
- FDA classified
- 18 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 21 Aug 2026 | Recall initiated by company | |
| 18 Sep 2026 | Classified by FDA | +28 days |
| 30 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Product as listed by the FDA
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Which lots are affected?
Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99641This product is part of a recall event; the main page for the event is IQvitals Zone, automatically recalled by Midmark.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IQvitals Zone, automatically recalled by Midmark | Midmark | Labeling Errors | Nationwide | |
| CLASS II | IQvitals Zone, automatically recalled by Midmark | Midmark | Labeling Errors | Nationwide | |
| CLASS II | IQvitals Zone, automatically recalled by Midmark | Midmark | Labeling Errors | Nationwide |
More recalls from Midmark
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IQvitals Zone, automatically recalled by Midmark | Midmark | Labeling Errors | Nationwide |
| Device | CLASS II | IQvitals Zone, automatically recalled by Midmark | Midmark | Labeling Errors | Nationwide |
| Device | CLASS II | IQvitals Zone, automatically recalled by Midmark | Midmark | Labeling Errors | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |
| Device | CLASS II | Digital ECG HD+12, HD+15 recalled by Midmark | Midmark | Labeling Errors | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |